Multiparticulates are established dosage forms that include multiple particles in which the aggregate of the particles represents the intended therapeutically useful dose of a therapeutic compound. After oral ingestion, the multiparticulates disperse in the gastrointestinal system to maximize absorption while minimizing side effects. Multiparticulates can be further processed into solid oral dosage forms, such as capsules, tablets and the like.
Alternatively multiparticulates can be directly administered without further processing as multiparticles, microparticles, minitablets, pellets, or beads.
A particularly useful type of multiparticulates is minitablets. Minitablets have a distinct shape and surface area which makes them particularly compatible with film coats, especially functional coatings. Traditionally, minitablets have been made from powder and/or granulate pharmaceutical blends on tablet presses. For example, rotary tablet presses with multiple compression stations may be used to press minitablets with exemplary output rates of about two million units per hour on production scale equipment.
Roller compactors, or chilsonators, are commonly used for dry granulation processes. A roller compactor forces fines, from a pharmaceutical blend, between rotating rollers in order to compact and densify the powders into a smaller volume forming a compact or sheet. The compacts or sheets are subsequently milled to form granules which may then be compressed into tablets.
The present invention features the use of roller compactors to directly form multiparticulates without the need of the use of a separate tablet press or tableting apparatus. Roller compactors allow the opportunity for a continuous production method rather than a batchwise process as found with tablet presses.